Purple Book product · Reference 351(a)

Herceptin

trastuzumab

351(a)BLA 103792Disc*Licensed Genentech, Inc.

View trastuzumab family Label PDF Open on FDA Purple Book

Sep 25, 1998

Approved

Reference 351(a)

License type

Disc*

Marketing

Listed patents

Herceptin (trastuzumab) is Genentech, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 1998. The FDA Purple Book lists 4 published patents for it, the last expiring 2031. 6 approved follow-on biologics reference Herceptin (Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti, and Hercessi).

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
Sep 25, 1998
28 yr 3 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Oct 20, 2017
8 yr 10 mo ago
Today

Pharmaceutical detail

Strength

420MG

Dosage form

For Injection

Route

Intravenous

Presentation

Multi-Dose Vial

Center

CDER

License number

1048

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. Its approved biosimilars and interchangeables are listed below.

1 additional BLA record for this product (other strengths or presentations) are in the same reference family.

Patent list (4)

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
Patent	Expires	In	Source
10,808,037	Jul 08, 2028	in 2 yr	FDA
11,078,294	Jul 08, 2028	in 2 yr	FDA
8,574,869	Jul 08, 2028	in 2 yr	FDA
10,662,237	Aug 07, 2031	in 5 yr 2 mo	FDA

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

Change history

v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

When do Herceptin's patents expire?

The FDA Purple Book lists 4 published patents for Herceptin, with the last listed patent expiring Aug 07, 2031. Every patent below links to its FDA source record so you can verify the expiration date.

Does Herceptin have approved biosimilars?

Yes. 6 approved follow-on biologics reference Herceptin in the Purple Book: Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti, and Hercessi.

What is Herceptin's BLA number?

Herceptin is licensed under BLA 103792, held by Genentech, Inc..

When was Herceptin approved by the FDA?

Herceptin was approved by the FDA on Sep 25, 1998.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo